Abstract 1933: Correlates of Bleeding After a 600 mg Loading Dose of Clopidogrel, With and Without Abciximab: A Pooled Analysis of 4 ISAR Randomized Trials.

Abstract

Background . Bleeding complications during PCI have been shown to be related to mortality. Little is known about the frequency and correlates of bleeding in patients (pts) undergoing PCI after a 600 mg loading dose of clopidogrel. Methods . We performed a pooled analysis of the ISAR-REACT, ISAR-SWEET, ISAR-SMART 2, and ISAR-REACT 2 trials in which 5,384 pts undergoing PCI ≥2 hours after a 600 mg loading dose of clopidogrel were randomized to receive abciximab or placebo. Bleeding was assessed using the Thombolysis in Myocardial Infarction (TIMI) scale. Multiple logistic regression model was used to identify independent correlates of 30-day bleeding; 22 standard clinical and procedural variables were analyzed. Pts receiving abciximab received a single bolus of 70 units/kg of heparin; those who did not received a single bolus of 140 units/kg. Results . Following the PCI procedure, 215 pts (4.0%) bled; bleeding was major in 59 pts (1.1%) and minor in 156 (2.9%). Pts who bled were older, more likely to be female, have a lower body mass index (BMI), have an acute coronary syndrome and multivessel disease, a lower left ventricular ejection fraction and slightly shorter lesions than pts without bleeding. Multiple logistic regression model revealed that female sex (odds ratio 2.06 [95% CI 1.52–2.79], p<0.001), lower BMI (per decrease of 5 kg/m 2 ) (1.54 [1.27–1.89], p<0.001), administration of abciximab (1.54 [1.15–2.04], p=0.003), age (per 10-year increase) (1.20 [1.03–1.41], p=0.02), and diameter stenosis (10% increase) (1.13 [1.03–1.24], p=0.008) were all independently associated with bleeding. Conclusion . Bleeding occurred in 4.0% of 5,384 pts who received a 600 mg loading dose of clopidogrel >2 hours, half of whom received abciximab, before a PCI in 4 ISAR trials. Abciximab was the only modifiable variable associated with bleeding. Abciximab should be utilized cautiously in women, older patients and those with lower BMI.